Quality Coordinator

IQVIA; Taguig; On-site; PHP 600,000 - 900,000; Full time

Job summary

IQVIA in Taguig, Philippines, is seeking a QA Database/Audit Specialist to maintain QA databases, manage audit plans, and support regulatory compliance across the QA lifecycle.

The role emphasizes data quality, CAPA management, and collaboration with Operations to improve processes, with shifting onsite schedules required.

Qualifications

• 5 years’ experience; equivalent combination of education, training and experience.
• Proficient in Microsoft Office software including Word, Excel and PowerPoint.
• Proficient in electronic data management software, EQMS in document management.
• Ability to review, approve, and publish electronic records.
• Excellent English written and verbal communication skills.
• Positive interaction skills, attention to detail, and organizational skills.
• Ability to handle multiple tasks and to follow through with completion of assigned tasks with some supervision.
• Good problem‑solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.
• Awareness of basic GxP requirements.
• Ability to learn scientific, medical, and regulatory terminology to gain an understanding of quality data and fields in QA database(s) to translate data user requests into specific queries required to independently generate requested metrics.
• Amenable to work onsite in Mckinley Taguig and shifting schedule.
• Amenable to work on shifting schedule.

Responsibilities

• Maintain QA databases and enter audits from audit plans/notifications; ensure system is updated.
• Follow up audit information through full lifecycle, gathering missing data and recording findings.
• Issue and distribute certificates and contracted audit documentation.
• Answer complex queries regarding use of EQMS to staff.
• Participate in validation processes such as User Acceptance Testing.
• Review and track documentation for global QA audits and CAPA.
• Maintain system to track signed audit plans and distribution.
• Maintain QA filing systems including electronic documentation.
• Produce reports from QA databases, including trends and overdue entries.
• Use metrics to optimize performance and efficiency of processes.
• Provide training on QA database maintenance and stay current with regulatory knowledge.
• Follow up and close audit/inspection CAPAs in the eQMS.
• Review and approve CAPA and effectiveness check plans.
• Categorize audit findings in the eQMS.
• Provide monthly QA activity reporting and training assessments.
• Prepare, deliver, and assess training with Operations input.

Skills

English proficiency

Attention to detail

Organizational skills

Multitasking

Problem-solving

Interpersonal skills

Tools

Microsoft Office (Word, Excel, PowerPoint)

EQMS (electronic data management)

Job description

Job Responsibilities

• Maintains the QA database(s) ensuring audits identified are entered onto the system from audit plans/notification documentation and the system is updated as required.
• Audit information is followed up as required, through the full audit life cycle including: missing information relating to the planned audits are identified, gathered and entered; performed audits are confirmed; the full text of audit findings are entered onto the database from sponsor/regulatory audit reports; follow‑up of reports and corrective and preventive actions and follow‑up of overdue critical/major findings.
• Certificates and contracted audit documentation are issued and distributed as appropriate.
• Provide support to staff by answering more complex queries concerning the use of EDA.
• Participate in systems validation process (such as User Acceptance Testing) as required.
• Review and track documentation related to the global QA auditing lifecycle (internal, external, contracted customer audits, regulatory inspections, regulatory audits, quality issues, corrective and preventive actions and status of critical/major issues).
• Maintain the system to track audit plans ensuring that signed audit plans are tracked, received and distributed.
• Maintain the QA filing systems for audits including electronic filing of documentation and correspondence.
• Produce documentation from the QA databases, including status reports of overdue information, tables and graphs, and reports illustrating overall trends for missing or overdue date entry requirements as required.
• Use metrics to optimize performance, productivity, and effectiveness of the processes and systems.
• Participate in the development and provide training on new/enhanced QA database maintenance processes, including providing training to new users involved in QA database maintenance; keep current in advances in area of expertise, including regulatory knowledge, trends, and developments, and complying with all required SOPs and timelines.
• Follow up and close audits/inspection corrective and preventive actions (CAPA) in the eQMS.
• Review and approve corrective and preventive actions (CAPA) and effectiveness check (EC) plans.
• Categorize audit/inspection findings in the eQMS.
• Regular reporting on training and QA activities, specifically monthly assessment and QA results.
• Training preparation, delivery, and assessment.
• Provide real‑time feedback, formulate action items and refresher trainings based on QA assessments in collaboration with Operations.

Job Qualifications

• 5 years’ experience; equivalent combination of education, training and experience.
• Proficient in Microsoft Office software including Word, Excel and PowerPoint.
• Proficient in electronic data management software, EQMS in document management.
• Ability to review, approve, and publish electronic records.
• Excellent English written and verbal communication skills.
• Positive interaction skills, attention to detail, and organizational skills.
• Ability to handle multiple tasks and to follow through with completion of assigned tasks with some supervision.
• Good problem‑solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.
• Awareness of basic GxP requirements.
• Ability to learn scientific, medical, and regulatory terminology to gain an understanding of quality data and fields in QA database(s) to translate data user requests into specific queries required to independently generate requested metrics.
• Amenable to work onsite in Mckinley Taguig and shifting schedule.
• Amenable to work on shifting schedule.